Summary of Number of Subjects By Site

The reference report's Table 14-1.03: intent-to-treat, efficacy and Week 24 completer counts per site and treatment group, small sites pooled under id 900.

Slug: t-subjects-by-site
Regulatory ID: DST04
Type: Table
E3 position: §14.1
Status: evidenced
Current iteration: v002
Datasets: adsl 1f6fa03
Evidence: 23/23 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-INTXT-001 DSP-INTXT-002 DSP-INTXT-003 DSP-REF-001 DSP-REF-002 DSP-REF-003 DSP-REF-004 DSP-SITE-001 DSP-SITE-002 STD-GATE-001 STD-GATE-002 STD-GATE-003 STD-GATE-004 STD-GATE-005 STD-MODEL-001 STD-MODEL-002 STD-MODEL-003 STD-MODEL-004 STD-MODEL-005 STD-SRC-001 STD-SRC-002
Used in: Clinical Study Report Table 14.1.5
Post-Text Display Package Table 14.1.5
Abbreviated Clinical Study Report (ICH E3) Table 14.1.5
Study model: All Randomised Subjects · grouped by TRT01P
Specification: 2 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: No text block binds it
Values: No value is sourced from it

Inputs

adsl254 rows · 1f6fa03
analysis.yamlwhat to compute
display.yamlhow to show it
study modelAll Randomised Subjects

Function

prepare_data()regenerate('t-subjects-by-site')
build_ard()one row per statistic
render_display()every variant
render_rtf()the same cells

Outputs

ard.jsonv002 · 612 rows · 6887f57
table.htmlthe rendered display
table.rtfsha256 0c9d104
table-in-text.rtfsha256 14eef94
manifest.jsonwho, why, every hash

RTFFull display0c9d104 RTFIn-text variant14eef94

Generated by the same pipeline run that wrote the ARD and the HTML above, from the same rendered cells; the short hash is the manifest's record of the file.

t-subjects-by-site · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo ITT (N=86)	Placebo Eff (N=79)	Placebo Com (N=60)	Low Dose ITT (N=84)	Low Dose Eff (N=81)	Low Dose Com (N=28)	High Dose ITT (N=84)	High Dose Eff (N=74)	High Dose Com (N=30)	Total ITT (N=254)	Total Eff (N=234)	Total Com (N=118)
Summary of Number of Subjects By Site
Study CDISCPILOT01 — All Subjects
701 / 701	14	14	11	13	13	5	14	14	7	41	41	23
703 / 703	6	5	4	6	5	1	6	5	2	18	15	7
704 / 704	9	9	5	8	7	3	8	8	0	25	24	8
705 / 705	5	3	2	5	5	3	6	4	1	16	12	6
708 / 708	9	9	7	8	8	2	8	5	2	25	22	11
709 / 709	7	7	5	7	6	2	7	7	3	21	20	10
710 / 710	11	8	6	10	10	2	10	8	5	31	26	13
713 / 713	3	3	3	3	3	2	3	2	2	9	8	7
716 / 716	8	8	7	8	8	3	8	8	3	24	24	13
718 / 718	4	4	3	5	5	1	4	4	1	13	13	5
900 / 702	0	0	0	1	1	0	0	0	0	1	1	0
900 / 706	1	1	1	1	1	0	1	1	0	3	3	1
900 / 707	1	1	1	1	1	0	0	0	0	2	2	1
900 / 711	1	1	1	1	1	0	2	1	0	4	3	1
900 / 714	2	2	2	2	2	1	2	2	1	6	6	4
900 / 715	3	2	2	3	3	1	2	2	0	8	7	3
900 / 717	2	2	0	2	2	2	3	3	3	7	7	5
TOTAL	86	79	60	84	81	28	84	74	30	254	234	118
ITT is the intent-to-treat population (ITTFL), Eff the efficacy population (EFFFL) and Com the subjects who completed Week 24 (COMP24FL), as the study's ADaM carries them and the reference report (Table 14-1.03) prints them.
Each row is one site, labelled with its pooled site id and its own id. Seven sites met the pre-specified criterion for small sample sizes and are pooled under id 900 for analyses that include site as a covariate; every site is listed on its own line, as in the reference.
Treatment groups are planned treatment, TRT01P, which agrees with actual treatment for every subject in this study. The Total column pools the three groups.
Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01.
open.csr display t-subjects-by-site (post_text variant); generated from the committed ARD.

Rendered from outputs/t-subjects-by-site/v002/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
itt	TRT01P	Placebo	—	—	SITEID	701	categorical	n	n	—	—	14
itt	TRT01P	Placebo	—	—	SITEID	701	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	701	categorical	p	%	—	—	0.162790697674419
itt	TRT01P	Placebo	—	—	SITEID	702	categorical	n	n	—	—	0
itt	TRT01P	Placebo	—	—	SITEID	702	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	702	categorical	p	%	—	—	0
itt	TRT01P	Placebo	—	—	SITEID	703	categorical	n	n	—	—	6
itt	TRT01P	Placebo	—	—	SITEID	703	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	703	categorical	p	%	—	—	0.0697674418604651
itt	TRT01P	Placebo	—	—	SITEID	704	categorical	n	n	—	—	9
itt	TRT01P	Placebo	—	—	SITEID	704	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	704	categorical	p	%	—	—	0.104651162790698
itt	TRT01P	Placebo	—	—	SITEID	705	categorical	n	n	—	—	5
itt	TRT01P	Placebo	—	—	SITEID	705	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	705	categorical	p	%	—	—	0.0581395348837209
itt	TRT01P	Placebo	—	—	SITEID	706	categorical	n	n	—	—	1
itt	TRT01P	Placebo	—	—	SITEID	706	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	706	categorical	p	%	—	—	0.0116279069767442
itt	TRT01P	Placebo	—	—	SITEID	707	categorical	n	n	—	—	1
itt	TRT01P	Placebo	—	—	SITEID	707	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	707	categorical	p	%	—	—	0.0116279069767442
itt	TRT01P	Placebo	—	—	SITEID	708	categorical	n	n	—	—	9
itt	TRT01P	Placebo	—	—	SITEID	708	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	708	categorical	p	%	—	—	0.104651162790698
itt	TRT01P	Placebo	—	—	SITEID	709	categorical	n	n	—	—	7
itt	TRT01P	Placebo	—	—	SITEID	709	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	709	categorical	p	%	—	—	0.0813953488372093
itt	TRT01P	Placebo	—	—	SITEID	710	categorical	n	n	—	—	11
itt	TRT01P	Placebo	—	—	SITEID	710	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	710	categorical	p	%	—	—	0.127906976744186
itt	TRT01P	Placebo	—	—	SITEID	711	categorical	n	n	—	—	1
itt	TRT01P	Placebo	—	—	SITEID	711	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	711	categorical	p	%	—	—	0.0116279069767442
itt	TRT01P	Placebo	—	—	SITEID	713	categorical	n	n	—	—	3
itt	TRT01P	Placebo	—	—	SITEID	713	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	713	categorical	p	%	—	—	0.0348837209302326
itt	TRT01P	Placebo	—	—	SITEID	714	categorical	n	n	—	—	2
itt	TRT01P	Placebo	—	—	SITEID	714	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	714	categorical	p	%	—	—	0.0232558139534884
itt	TRT01P	Placebo	—	—	SITEID	715	categorical	n	n	—	—	3
itt	TRT01P	Placebo	—	—	SITEID	715	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	715	categorical	p	%	—	—	0.0348837209302326
itt	TRT01P	Placebo	—	—	SITEID	716	categorical	n	n	—	—	8
itt	TRT01P	Placebo	—	—	SITEID	716	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	716	categorical	p	%	—	—	0.0930232558139535
itt	TRT01P	Placebo	—	—	SITEID	717	categorical	n	n	—	—	2
itt	TRT01P	Placebo	—	—	SITEID	717	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	717	categorical	p	%	—	—	0.0232558139534884
itt	TRT01P	Placebo	—	—	SITEID	718	categorical	n	n	—	—	4
itt	TRT01P	Placebo	—	—	SITEID	718	categorical	N	N	—	—	86
itt	TRT01P	Placebo	—	—	SITEID	718	categorical	p	%	—	—	0.0465116279069767
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	701	categorical	n	n	—	—	13
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	701	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	701	categorical	p	%	—	—	0.154761904761905
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	702	categorical	n	n	—	—	1
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	702	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	702	categorical	p	%	—	—	0.0119047619047619
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	703	categorical	n	n	—	—	6
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	703	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	703	categorical	p	%	—	—	0.0714285714285714
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	704	categorical	n	n	—	—	8
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	704	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	704	categorical	p	%	—	—	0.0952380952380952
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	705	categorical	n	n	—	—	5
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	705	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	705	categorical	p	%	—	—	0.0595238095238095
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	706	categorical	n	n	—	—	1
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	706	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	706	categorical	p	%	—	—	0.0119047619047619
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	707	categorical	n	n	—	—	1
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	707	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	707	categorical	p	%	—	—	0.0119047619047619
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	708	categorical	n	n	—	—	8
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	708	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	708	categorical	p	%	—	—	0.0952380952380952
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	709	categorical	n	n	—	—	7
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	709	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	709	categorical	p	%	—	—	0.0833333333333333
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	710	categorical	n	n	—	—	10
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	710	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	710	categorical	p	%	—	—	0.119047619047619
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	711	categorical	n	n	—	—	1
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	711	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	711	categorical	p	%	—	—	0.0119047619047619
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	713	categorical	n	n	—	—	3
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	713	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	713	categorical	p	%	—	—	0.0357142857142857
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	714	categorical	n	n	—	—	2
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	714	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	714	categorical	p	%	—	—	0.0238095238095238
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	715	categorical	n	n	—	—	3
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	715	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	715	categorical	p	%	—	—	0.0357142857142857
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	716	categorical	n	n	—	—	8
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	716	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	716	categorical	p	%	—	—	0.0952380952380952
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	717	categorical	n	n	—	—	2
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	717	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	717	categorical	p	%	—	—	0.0238095238095238
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	718	categorical	n	n	—	—	5
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	718	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline Low Dose	—	—	SITEID	718	categorical	p	%	—	—	0.0595238095238095
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	701	categorical	n	n	—	—	14
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	701	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	701	categorical	p	%	—	—	0.166666666666667
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	702	categorical	n	n	—	—	0
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	702	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	702	categorical	p	%	—	—	0
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	703	categorical	n	n	—	—	6
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	703	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	703	categorical	p	%	—	—	0.0714285714285714
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	704	categorical	n	n	—	—	8
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	704	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	704	categorical	p	%	—	—	0.0952380952380952
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	705	categorical	n	n	—	—	6
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	705	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	705	categorical	p	%	—	—	0.0714285714285714
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	706	categorical	n	n	—	—	1
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	706	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	706	categorical	p	%	—	—	0.0119047619047619
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	707	categorical	n	n	—	—	0
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	707	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	707	categorical	p	%	—	—	0
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	708	categorical	n	n	—	—	8
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	708	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	708	categorical	p	%	—	—	0.0952380952380952
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	709	categorical	n	n	—	—	7
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	709	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	709	categorical	p	%	—	—	0.0833333333333333
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	710	categorical	n	n	—	—	10
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	710	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	710	categorical	p	%	—	—	0.119047619047619
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	711	categorical	n	n	—	—	2
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	711	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	711	categorical	p	%	—	—	0.0238095238095238
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	713	categorical	n	n	—	—	3
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	713	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	713	categorical	p	%	—	—	0.0357142857142857
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	714	categorical	n	n	—	—	2
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	714	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	714	categorical	p	%	—	—	0.0238095238095238
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	715	categorical	n	n	—	—	2
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	715	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	715	categorical	p	%	—	—	0.0238095238095238
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	716	categorical	n	n	—	—	8
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	716	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	716	categorical	p	%	—	—	0.0952380952380952
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	717	categorical	n	n	—	—	3
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	717	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	717	categorical	p	%	—	—	0.0357142857142857
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	718	categorical	n	n	—	—	4
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	718	categorical	N	N	—	—	84
itt	TRT01P	Xanomeline High Dose	—	—	SITEID	718	categorical	p	%	—	—	0.0476190476190476
itt	TRT01P	Total	—	—	SITEID	701	categorical	n	n	—	—	41
itt	TRT01P	Total	—	—	SITEID	701	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	701	categorical	p	%	—	—	0.161417322834646
itt	TRT01P	Total	—	—	SITEID	702	categorical	n	n	—	—	1
itt	TRT01P	Total	—	—	SITEID	702	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	702	categorical	p	%	—	—	0.00393700787401575
itt	TRT01P	Total	—	—	SITEID	703	categorical	n	n	—	—	18
itt	TRT01P	Total	—	—	SITEID	703	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	703	categorical	p	%	—	—	0.0708661417322835
itt	TRT01P	Total	—	—	SITEID	704	categorical	n	n	—	—	25
itt	TRT01P	Total	—	—	SITEID	704	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	704	categorical	p	%	—	—	0.0984251968503937
itt	TRT01P	Total	—	—	SITEID	705	categorical	n	n	—	—	16
itt	TRT01P	Total	—	—	SITEID	705	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	705	categorical	p	%	—	—	0.062992125984252
itt	TRT01P	Total	—	—	SITEID	706	categorical	n	n	—	—	3
itt	TRT01P	Total	—	—	SITEID	706	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	706	categorical	p	%	—	—	0.0118110236220472
itt	TRT01P	Total	—	—	SITEID	707	categorical	n	n	—	—	2
itt	TRT01P	Total	—	—	SITEID	707	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	707	categorical	p	%	—	—	0.0078740157480315
itt	TRT01P	Total	—	—	SITEID	708	categorical	n	n	—	—	25
itt	TRT01P	Total	—	—	SITEID	708	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	708	categorical	p	%	—	—	0.0984251968503937
itt	TRT01P	Total	—	—	SITEID	709	categorical	n	n	—	—	21
itt	TRT01P	Total	—	—	SITEID	709	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	709	categorical	p	%	—	—	0.0826771653543307
itt	TRT01P	Total	—	—	SITEID	710	categorical	n	n	—	—	31
itt	TRT01P	Total	—	—	SITEID	710	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	710	categorical	p	%	—	—	0.122047244094488
itt	TRT01P	Total	—	—	SITEID	711	categorical	n	n	—	—	4
itt	TRT01P	Total	—	—	SITEID	711	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	711	categorical	p	%	—	—	0.015748031496063
itt	TRT01P	Total	—	—	SITEID	713	categorical	n	n	—	—	9
itt	TRT01P	Total	—	—	SITEID	713	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	713	categorical	p	%	—	—	0.0354330708661417
itt	TRT01P	Total	—	—	SITEID	714	categorical	n	n	—	—	6
itt	TRT01P	Total	—	—	SITEID	714	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	714	categorical	p	%	—	—	0.0236220472440945
itt	TRT01P	Total	—	—	SITEID	715	categorical	n	n	—	—	8
itt	TRT01P	Total	—	—	SITEID	715	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	715	categorical	p	%	—	—	0.031496062992126
itt	TRT01P	Total	—	—	SITEID	716	categorical	n	n	—	—	24
itt	TRT01P	Total	—	—	SITEID	716	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	716	categorical	p	%	—	—	0.094488188976378
itt	TRT01P	Total	—	—	SITEID	717	categorical	n	n	—	—	7
itt	TRT01P	Total	—	—	SITEID	717	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	717	categorical	p	%	—	—	0.0275590551181102
itt	TRT01P	Total	—	—	SITEID	718	categorical	n	n	—	—	13
itt	TRT01P	Total	—	—	SITEID	718	categorical	N	N	—	—	254
itt	TRT01P	Total	—	—	SITEID	718	categorical	p	%	—	—	0.0511811023622047
eff	TRT01P	Placebo	—	—	SITEID	701	categorical	n	n	—	—	14
eff	TRT01P	Placebo	—	—	SITEID	701	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	701	categorical	p	%	—	—	0.177215189873418
eff	TRT01P	Placebo	—	—	SITEID	702	categorical	n	n	—	—	0
eff	TRT01P	Placebo	—	—	SITEID	702	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	702	categorical	p	%	—	—	0
eff	TRT01P	Placebo	—	—	SITEID	703	categorical	n	n	—	—	5
eff	TRT01P	Placebo	—	—	SITEID	703	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	703	categorical	p	%	—	—	0.0632911392405063
eff	TRT01P	Placebo	—	—	SITEID	704	categorical	n	n	—	—	9
eff	TRT01P	Placebo	—	—	SITEID	704	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	704	categorical	p	%	—	—	0.113924050632911
eff	TRT01P	Placebo	—	—	SITEID	705	categorical	n	n	—	—	3
eff	TRT01P	Placebo	—	—	SITEID	705	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	705	categorical	p	%	—	—	0.0379746835443038
eff	TRT01P	Placebo	—	—	SITEID	706	categorical	n	n	—	—	1
eff	TRT01P	Placebo	—	—	SITEID	706	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	706	categorical	p	%	—	—	0.0126582278481013
eff	TRT01P	Placebo	—	—	SITEID	707	categorical	n	n	—	—	1
eff	TRT01P	Placebo	—	—	SITEID	707	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	707	categorical	p	%	—	—	0.0126582278481013
eff	TRT01P	Placebo	—	—	SITEID	708	categorical	n	n	—	—	9
eff	TRT01P	Placebo	—	—	SITEID	708	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	708	categorical	p	%	—	—	0.113924050632911
eff	TRT01P	Placebo	—	—	SITEID	709	categorical	n	n	—	—	7
eff	TRT01P	Placebo	—	—	SITEID	709	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	709	categorical	p	%	—	—	0.0886075949367089
eff	TRT01P	Placebo	—	—	SITEID	710	categorical	n	n	—	—	8
eff	TRT01P	Placebo	—	—	SITEID	710	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	710	categorical	p	%	—	—	0.10126582278481
eff	TRT01P	Placebo	—	—	SITEID	711	categorical	n	n	—	—	1
eff	TRT01P	Placebo	—	—	SITEID	711	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	711	categorical	p	%	—	—	0.0126582278481013
eff	TRT01P	Placebo	—	—	SITEID	713	categorical	n	n	—	—	3
eff	TRT01P	Placebo	—	—	SITEID	713	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	713	categorical	p	%	—	—	0.0379746835443038
eff	TRT01P	Placebo	—	—	SITEID	714	categorical	n	n	—	—	2
eff	TRT01P	Placebo	—	—	SITEID	714	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	714	categorical	p	%	—	—	0.0253164556962025
eff	TRT01P	Placebo	—	—	SITEID	715	categorical	n	n	—	—	2
eff	TRT01P	Placebo	—	—	SITEID	715	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	715	categorical	p	%	—	—	0.0253164556962025
eff	TRT01P	Placebo	—	—	SITEID	716	categorical	n	n	—	—	8
eff	TRT01P	Placebo	—	—	SITEID	716	categorical	N	N	—	—	79
eff	TRT01P	Placebo	—	—	SITEID	716	categorical	p	%	—	—	0.10126582278481
eff	TRT01P	Placebo	—	—	SITEID	717	categorical	n	n	—	—	2

Showing the first 250 of 612 rows — the full ARD is committed beside the display.

Schema: opencsr/ard/v1
Generated: 2026-09-02T16:15:18Z
Spec hash: sha256:9b145f6fe1f753e6a3729e757993d5ec669b342acacc0113077a63e9c112b56f
Display hash: sha256:3087fc570f550d7fdbfd30ed702860c09478358c9e310a12b02f9cbab1676108
ARD file: outputs/t-subjects-by-site/v002/ard.json
ARD hash: sha256:6887f57cfc4987e81823c8de7a4d6a2e452ea55848294db90f1997ccdf0d9747

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:1f6fa03914a74aa185bd5ee8453806779abe240f7b88f483d932b8eec9680da6

Environment

R 4.3.3 · Darwin 23.6.0 · cards 0.6.1 · cardx 0.2.5 · gtsummary 2.3.0 · gt 1.0.0 · dplyr 1.1.4 · pharmaverseadam 1.1.0 · jsonlite 2.0.0 · yaml 2.3.10 · digest 0.6.37

library/tfl/t-subjects-by-site/analysis.yaml

# ------------------------------------------------------------------------------
# t-subjects-by-site — Summary of Number of Subjects By Site
# ------------------------------------------------------------------------------
# Target: Table 14-1.03 of the CDISCPILOT01 clinical study report (27 June 2006),
# page 45. All subjects. One row per site — the seven small sites pooled under
# id 900 for analyses that adjust for site, each still listed on its own line —
# and, per arm and for the total, the subjects in the intent-to-treat, efficacy
# and Week 24 completer populations. Twelve columns, then a TOTAL line.
#
# Three analyses, one per population, each a categorical count of SITEID over
# the subjects carrying that population's flag; the display's twelve columns are
# arm × analysis, which is what column objects are for (#63).
# ------------------------------------------------------------------------------
id: t-subjects-by-site
title: "Summary of Number of Subjects By Site"
regulatory_id: DST04
type: table
dataset: adsl
analysis_set: all
denominator: adsl
group:
  - TRT01P
total: true
analyses:
  - name: itt
    method: categorical
    label: "Intent-to-treat subjects by site"
    variables: [SITEID]
    filter: "ITTFL == 'Y'"
  - name: eff
    method: categorical
    label: "Efficacy subjects by site"
    variables: [SITEID]
    filter: "EFFFL == 'Y'"
  - name: com
    method: categorical
    label: "Week 24 completers by site"
    variables: [SITEID]
    filter: "COMP24FL == 'Y'"

library/tfl/t-subjects-by-site/display.yaml

id: t-subjects-by-site
title: "Summary of Number of Subjects By Site"
study: CDISCPILOT01
population_label: "All Subjects"
cutoff: "2014-07-01"
source: "Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01."
footnotes:
  - "ITT is the intent-to-treat population (ITTFL), Eff the efficacy population (EFFFL) and Com the subjects who completed Week 24 (COMP24FL), as the study's ADaM carries them and the reference report (Table 14-1.03) prints them."
  - "Each row is one site, labelled with its pooled site id and its own id. Seven sites met the pre-specified criterion for small sample sizes and are pooled under id 900 for analyses that include site as a covariate; every site is listed on its own line, as in the reference."
  - "Treatment groups are planned treatment, TRT01P, which agrees with actual treatment for every subject in this study. The Total column pools the three groups."
columns:
  order:
    - { label: "Placebo ITT", group: Placebo, analysis: itt }
    - { label: "Placebo Eff", group: Placebo, analysis: eff }
    - { label: "Placebo Com", group: Placebo, analysis: com }
    - { label: "Low Dose ITT", group: "Xanomeline Low Dose", analysis: itt }
    - { label: "Low Dose Eff", group: "Xanomeline Low Dose", analysis: eff }
    - { label: "Low Dose Com", group: "Xanomeline Low Dose", analysis: com }
    - { label: "High Dose ITT", group: "Xanomeline High Dose", analysis: itt }
    - { label: "High Dose Eff", group: "Xanomeline High Dose", analysis: eff }
    - { label: "High Dose Com", group: "Xanomeline High Dose", analysis: com }
    - { label: "Total ITT", group: Total, analysis: itt }
    - { label: "Total Eff", group: Total, analysis: eff }
    - { label: "Total Com", group: Total, analysis: com }
format:
  count: "{n}"
  zero_count: "0"
rows:
  - { analysis: itt, variable: SITEID, levels: all, pattern: count, indent: 0,
      level_order: ["701", "703", "704", "705", "708", "709", "710", "713", "716", "718", "702", "706", "707", "711", "714", "715", "717"],
      level_labels: { "701": "701 / 701", "703": "703 / 703", "704": "704 / 704", "705": "705 / 705", "708": "708 / 708", "709": "709 / 709", "710": "710 / 710", "713": "713 / 713", "716": "716 / 716", "718": "718 / 718", "702": "900 / 702", "706": "900 / 706", "707": "900 / 707", "711": "900 / 711", "714": "900 / 714", "715": "900 / 715", "717": "900 / 717" } }
  - { analysis: itt, variable: SITEID, pattern: "{N}", label: "TOTAL", indent: 0 }
variants:
  post_text: {}
  in_text:
    title: "Subjects by Site (Summary)"

Every iteration is kept: outputs/t-subjects-by-site/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.